Biomet Recalls HipLOC Hip Fracture Fixation System Plates
Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) as it involves a risk of harm where injury has not yet been reported or is theoretically reversible.
Plain-English summary
Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System, specifically the Hiploc System 135° Plate 38 mm Barrel 4 Hole Plate (Item Number: 2110-135-004). The recall is due to an undersized bore on the HipLOC plate barrel, which can result in the lag screw not fitting through the barrel.
The affected products were distributed nationwide in the United States, specifically in the states of Arizona, Missouri, New Jersey, and New Mexico. The recall involves specific lot numbers, including 3222067, 3355792, 3609499, and others listed in the agency records.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Biomet UK Ltd. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal…
- Manufacturer
- Biomet UK Ltd.
- Affected units
- 44
Distribution
Part of a larger recall action
This product is one of 4 recalled by Biomet UK Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Biomet UK Ltd.
See all →- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues
FDA (Devices) · 2018-10-03
- HighBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03
- SevereBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03
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